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  • FDA Looks to Support Animal Rule With New GLP Training Program

    • 15 June 2012
    How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs). In an advanced posting of an 18 June Federal Register ...
  • EMA Adopts Reflection Paper on Evaluating Clinical Trial Samples

    The European Medicines Agency (EMA) adopted a reflection paper that aims to provide quality systems guidance for laboratories in charge of analyzing and evaluating samples generated from clinical trials. Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples , adopted 28 February and released 20 March, intends to provide clinical laboratories "with information that will help them develop and maintain quality systems" that com...